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Principal Medical Writer - Oncology and Rare Disease

Company: PRA Health Sciences
Location: Remote
Posted on: June 10, 2021

Job Description:

Overview

Who are we?

We Are PRA.

We are 20,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

Who Are You?

You are an experience professional with a passion for Medical Writing. You are organized, but flexible and adaptable to unexpected changes. You can easily envision the bigger picture, without losing sight of the day-to-day tasks. You can provide excellent leadership to not only your project teams, but also to clients. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. Most of all, you want to do it in a place where you're more than an employee number. A place you love working.

Still here? Good. Because if this is you, we'd really like to meet you.

Responsibilities

What will you be doing?

Researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge. Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents. Exhibits excellent written and oral communication and presentation skills. Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).

What do you need to have?

  • Manages all aspects of the medical writing function.
  • Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents.
  • Contributes to clinical protocol development for first-in-human oncology studies.
  • Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).
  • Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents
  • Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers.
  • Acts as a lead medical writer on complex programs and numerous individual studies.
  • Provides scientific and medical writing consultancy to project teams, as requested.

Qualifications

Qualifications

  • Advanced degree in a relevant scientific/clinical/regulatory field preferred
  • At least 5 years of experience in a lead oncology medical writing role in the pharmaceutical/CRO industry. *Note: Early development oncology experience is preferred.
  • Excellent writing skills.
  • Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
  • Knowledge of current requirements and guidelines applicable to submission documents
  • Excellent interpersonal and oral communication skills.
  • Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Ability to prioritize multiple projects
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Keywords: PRA Health Sciences, Eugene , Principal Medical Writer - Oncology and Rare Disease, Other , Remote, Oregon

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